FDA accepts resubmitted Lemtrada sBLA

The Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) said FDA accepted for review a resubmitted sBLA for Lemtrada alemtuzumab to treat relapsing multiple sclerosis (MS). Genzyme said it expects a decision in 4Q14; the specific PDUFA date is not disclosed. FDA issued a complete response letter for Lemtrada in December. According to the company, FDA said at least one additional comparator trial with a "different design and execution" would be needed for Lemtrada's approval. Genzyme said the resubmitted sBLA includes the same studies as the original sBLA along with "supplemental analyses and additional information" to address FDA's issues, but declined to disclose details (see BioCentury Extra, Dec. 30, 2013). ...